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OpenTrials
Completed

NCT Number: NCT01318265

Effect of Ketoconazole on Regorafenib (BAY73-4506) Pharmacokinetics

The purpose of this study is to estimate the effect of multiple doses of ketoconazole on the pharmacokinetics of a single dose of BAY73-4506 in healthy male volunteers.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Brighton, Massachusetts, 02135, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male subjects between 18 and 45 years of age, inclusive
  • BMI between 18 and 32 kg/m2 inclusive

Exclusion criteria

  • Subjects with evidence of disease, conditions affecting drug absorption or metabolism
  • Treatment with other investigational drug within 30 days
  • History of regular alcohol or recreational drug consumption
  • Use of prescription drugs within 14 days
  • Use of nonprescription drugs and dietary supplement within 7 days
  • Blood donation within 30 days

Treatment and study plan

Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole

Drug

Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.

Primary outcomes

  1. Area under the plasma concentration versus time curve from zero to infinity ( Plasma AUCinf) of BAY73-4506 given alone or with ketoconazole.

    Time frame: 1 month

  2. Peak plasma concentration (Cmax) of BAY73-4506 given alone or with ketoconazole

    Time frame: 1 month

Secondary outcomes

  1. Plasma AUCinf of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

    Time frame: 1 month

  2. Plasma Cmax of metabolites of a single oral dose BAY73-4506 given alone or with ketoconazole.

    Time frame: 1 month

  3. Number of subjects with adverse events following a single oral dose of BAY73-4506, adminstered alone and concomitantly with ketoconazole.

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

A Phase I, Non-Randomized, Open Label Study to Determine the Effetc of Ketoconazole on the Pharmacokinetics of a Single Oral Dose of Regorafenib (BAY73-4506) in Healthy Volunteers

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 18, 2011
Registry last updated
Nov 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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